Class IIReported 2025-01-15
Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
Recalled by Rising Pharma Holding, Inc.
Reason for Recall
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
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Recall NumberD-0189-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2024-12-30Reported2025-01-15DistributionNationwideCode InfoLot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.